Endoscopic bypass grafting method utilizing an inguinal approach

ABSTRACT

A method for implanting an end portion of a graft within the body of a patient during a bypass grafting procedure is disclosed. The body has a circulatory system which includes a femoral artery and an aorta. The method includes the steps of (i) making an incision in the body of the patient so as to expose the femoral artery and an inguinal ligament, (ii) advancing an endoscope between the femoral artery and the inguinal ligament until a distal end of the endoscope is positioned at a working site within the body, (iii) advancing the end portion of the graft between the femoral artery and the inguinal ligament to the working site, wherein said end portion advancing step includes the step of advancing the end portion of the graft through the endoscope, and (iv) forming an anastomosis between the end portion of the graft and the aorta at the working site.

RELATED CASES

This application is a continuation of application Ser. No. 10/165,460,filed on Jun. 7, 2002 now abandoned, which application is a continuationof application Ser. No. 09/436,321, filed Nov. 8, 1999, now issued asU.S. Pat. No. 6,401,721, which is a continuation of application Ser. No.09/073,336, filed May 5, 1998, and now issued as U.S. Pat. No.5,979,455, which is a continuation of application Ser. No. 08/702,742,filed Aug. 23, 1996, now issued as U.S. Pat. No. 5,749,375, which is acontinuation of application Ser. No. 08/391,960, filed Feb. 21, 1995,now-issued as U.S. Pat. No. 5,571,167, which is a continuation ofapplication Ser. No. 08/138,912, filed Oct. 18, 1993, now issued as U.S.Pat. No. 5,456,712, which is a division of application Ser. No.08/056,371, filed on May 3, 1993, now U.S. Pat. No. 5,304,220, which isa continuation-in-part of application Ser. No. 07/725,597, filed on Jul.3, 1991, now issued U.S. Pat. No. 5,211,683.

BACKGROUND OF THE INVENTION

The present invention relates generally to a method for improving bloodflow in the body of a patient and more particularly concerns anendoscopic bypass grafting method which utilizes an inguinal approach.

Treatment of vascular disease in which the lumen of a blood vessel issignificantly narrowed or occluded by atherosclerosis includes surgicaland endovascular methods. Conventional surgical methods includeobtaining access to a blood vessel via one or more surgical incisionsand either removing the blockage by performing an endarterectomy orbypassing the blockage by placing a bypass graft which has a generallycylindrical shape. Endovascular methods include obtaining access to ablood vessel with a catheter and improving blood flow therein byperforming an athrectomy, atherolysis, or balloon and laser angioplastywith or without endovascular stent placement. In general, the preferredtreatment of severe stenosis or occlusion of a long vessel segment hasbeen surgical bypass grafting.

Although conventional surgical bypass grafting is an accepted procedure,it presents substantial morbidity and mortality risks. Also, not allpatients are acceptable candidates for the above surgical procedure dueto advanced age and preexisting medical conditions. Moreover,conventional surgical bypass grafting is an invasive procedure which mayrequire extended hospitalization due to postoperative recovery. Inaddition, the above surgical procedure may involve substantial financialcosts to patients, hospitals and society in general. Further, incisionsmade during the above surgical procedure may cause significantcosmetically unattractive scarring which is undesirable to manypatients.

What is needed therefore is method for implanting an end portion of agraft within the body of a patient which overcomes one or more of theabove-mentioned disadvantages.

SUMMARY OF THE INVENTION

One embodiment of the present invention involves a method for implantingan end portion of a graft within the body of a patient during a bypassgrafting procedure is disclosed. The body has a circulatory system whichincludes a femoral artery and an aorta. The method includes the steps of(i) making an incision in the body of the patient so as to expose thefemoral artery and an inguinal ligament, (ii) advancing an endoscopebetween the femoral artery and the inguinal ligament until a distal endof the endoscope is positioned at a working site within the body, (iii)advancing the end portion of the graft between the femoral artery andthe inguinal ligament to the working site, wherein said end portionadvancing step includes the step of advancing the end portion of thegraft through the endoscope, and (iv) forming an anastomosis between theend portion of the graft and the aorta at the working site.

One object of the present invention is to an improved method forimplanting an end portion of a graft within the body of a patient.

Other objects and benefits of the present invention can be discernedfrom the following description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary front elevational view of a human body showing ablood vessel which includes the aorta, the right common iliac artery,the right common femoral artery and the left common femoral arterywherein a segment of the blood vessel is occluded. FIG. 1 also shows aportion of each inguinal ligament of the human body.

FIG. 2 is an enlarged fragmentary view of the human body and bloodvessel of FIG. 1.

FIG. 3 shows the human body and blood vessel of FIG. 2 with aballoon-tip catheter positioned within the blood vessel wherein theballoon is inflated in accordance with the preferred method of thepresent invention.

FIG. 4 is a view similar to FIG. 3 but showing a second balloon-tipcatheter positioned within the blood vessel wherein the second balloonis inflated in accordance with the preferred method of the presentinvention.

FIG. 5 is a view similar to FIG. 4 but showing the blood vessel inphantom except for a portion thereof that is exposed through a gapingsurgical incision. Also shown exposed through the surgical incision inFIG. 5 is a portion of the right inguinal ligament.

FIG. 6 is a view similar to FIG. 5 but showing another portion of theblood vessel, including the aorta, exposed for clarity of description.Moreover, in FIG. 6, a laparoscope (depicted schematically) is showninserted through the surgical incision in accordance with the preferredmethod of the present invention.

FIG. 7 is a view similar to FIG. 6 but showing a needle positionedwithin the laparoscope in accordance with the preferred method of thepresent invention.

FIG. 8 is a view similar to FIG. 7 but showing the needle removed fromthe laparoscope and replaced with a scissors device in accordance withthe preferred method of the present invention.

FIG. 9A is an elevational view of a graft prosthesis used in carryingout the preferred method of the present invention.

FIG. 9B is a fragmentary sectional view taken along the line 9B—9B ofFIG. 9A as viewed in the direction of the arrows.

FIG. 9C is a fragmentary perspective view of the graft prosthesis ofFIG. 9A showing its outwardly extending flanged end portion.

FIG. 9D is another fragmentary perspective view of the graft prosthesisof FIG. 9A showing its outwardly extending flanged end portion.

FIG. 9E is a view similar to FIG. 9C but showing a plurality of springs,in phantom, integrally positioned within the outwardly extending flangedend portion, in addition to, a portion of the sidewalls of the graftprosthesis of FIG. 9A.

FIG. 9F is an elevational view of one of the plurality of springs ofFIG. 9E.

FIG. 9G is an elevational view of another of the plurality of springs ofFIG. 9E.

FIG. 9H is an elevational view of yet another of the plurality ofsprings of FIG. 9E.

FIG. 9I is an elevational view of still another of the plurality ofsprings of FIG. 9E.

FIG. 10A is an elevational view of the graft prosthesis of FIG. 9Awherein the graft prosthesis is in a rolled configuration.

FIG. 10B is a cross-sectional view taken along the line 10B—10B of FIG.10A as viewed in the direction of the arrows.

FIG. 11A is an elevational view of the laparoscope of FIG. 6. Moreover,FIG. 11A shows the graft prosthesis of FIG. 10A, positioned within thelaparoscope in accordance with the method of the present invention. FIG.11A further shows a plunger, used in carrying out the preferred methodof the present invention, partially positioned within the laparoscope inaccordance with the preferred method of the present invention.

FIG. 11B is a cross-sectional view taken along the line 11B–11B of FIG.11A as viewed in the direction of the arrows.

FIG. 12 is a view similar to FIG. 8 but showing the scissors deviceremoved from the laparoscope and replaced with the graft prosthesis andis plunger of FIG. 11A in accordance with the preferred method of thepresent invention.

FIG. 13 is a view similar to FIG. 12 but showing the graft prosthesisbeing advanced out the distal end of the laparoscope in accordance withthe preferred method of the present invention.

FIG. 14 is a view similar to FIG. 13 but showing the graft prosthesisbeing further advanced out the distal end of the laparoscope inaccordance with the preferred method of the present invention.

FIG. 15 is a view similar to FIG. 14 but showing the graft prosthesisbeing yet further advanced out the distal end of the laparoscope inaccordance with the preferred method of the present invention.

FIG. 16 is a view similar to FIG. 15 but showing the laparoscope removedfrom the surgical incision and showing the graft prosthesis after it hadreverted back to its prerolled configuration in accordance with thepreferred method of the present invention.

FIG. 17 is a view similar to FIG. 16 but showing a third balloon-tipcatheter having a balloon thereon and further having an expandablestent, in its unexpanded state, positioned over the balloon, advanced toa position within the blood vessel in accordance with the preferredmethod of the present invention.

FIG. 18 is a view similar to FIG. 17 but showing the balloon of thethird balloon-tip catheter inflated so as to expand the stent in to itsexpanded configuration in accordance with the preferred method of thepresent invention.

FIG. 19A is a view similar to FIG. 18 but showing the third balloon-tipcatheter removed from the blood vessel and showing the stent expanded toform an anastomosis between one end of the graft prosthesis and theblood vessel in accordance with the preferred method of the presentinvention.

FIG. 19B is an enlarged schematic side elevational view showing a numberof sutures tied to the sidewall of the blood vessel so as to secure theend portion of the graft and the stent thereto as a possible additionalprocedure in order to further ensure the integrity of the anastomosis ofFIG. 19A.

FIG. 19C is a cross-sectional view taken along the line 19C–19C of FIG.19B as viewed in the direction of the arrows.

FIG. 19D is a view similar to FIG. 19A but showing a laparoscope(depicted schematically) inserted through an incision in the epidermisof the body and into the peritoneal cavity, and further showing agrasper holding a curved needle with an end of a suture attached theretowherein the distal end of the grasper is positioned at the upstreamsite.

FIG. 19E is an enlarged schematic side elevational view showing a numberof sutures tied to the sidewall of the blood vessel so as to secure theend portion of the graft thereto (without the use of the stent), whereinthe end portion of the graft is positioned within the upstream isolatedregion, as an alternative procedure in forming an anastomosis betweenthe end portion of the graft and the blood vessel.

FIG. 19F is a cross-sectional view taken along the line 19F—19F of FIG.19E as viewed in the direction of the arrows.

FIG. 19G is an enlarged schematic side elevational view showing a numberof sutures tied to the sidewall of the blood vessel so as to secure theend portion of the graft thereto (without the use of the stent), whereinthe end portion of the graft is positioned outside of the upstreamisolated region, as another alternative procedure in forming ananastomosis between the end portion of the graft and the blood vessel.

FIG. 19H is a cross-sectional view taken along the line 19H–19H of FIG.19G as viewed in the direction of the arrows.

FIG. 20A is an enlarged side elevational view showing the anastomosis ofFIG. 19A.

FIG. 20B is a cross-sectional view taken along the line 20B—20B of FIG.20A as viewed in the direction of the arrows.

FIG. 20C is a cross-sectional view taken along the line 20C—20C of FIG.20A as viewed in the direction of the arrows.

FIG. 21 is a view similar to FIG. 19A but showing a pair of clampspositioned on the blood vessel in accordance with the preferred methodof the present invention.

FIG. 22 is a view similar to FIG. 21 but showing an arteriotomy formedin the sidewall of the blood vessel in accordance with the preferredmethod of the present invention.

FIG. 23 is a view similar to FIG. 22 but showing an anastomosis formedbetween the other end the graft prosthesis and the blood vessel inaccordance with the preferred method of the present invention.

FIG. 24 is a view similar to FIG. 23 but showing the first balloon-tipcatheter and the second balloon-tip catheter removed from the bloodvessel in accordance with the preferred method of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments and methodsillustrated in the drawings and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the invention is thereby intended, such alterations andfurther modifications in the illustrated devices and methods, and suchfurther applications of the principles of the invention as illustratedtherein being contemplated as would normally occur to one skilled in theart to which the invention relates.

Referring now to the drawings, FIG. 1 shows a portion of a human body,generally designated by the reference numeral 10, with an artery, thecommon iliac artery 12, having an occluded segment, generally designatedby the reference numeral 14. Human body 10 is further shown having otherarteries, in particular; aorta 16, right common femoral artery 18, leftcommon femoral artery 30 and renal arteries 20. In addition, human body10 includes a right inguinal ligament 19 and a left inguinal ligament29. Human body 10 also includes an epidermis 13 (see e.g. FIG. 6). Thepreferred method disclosed herein describes the implantation of a graftto couple aorta 16 to right common femoral artery 18 thereby bypassingoccluded segment 14. FIG. 2 shows an enlarged view of aorta 16, rightcommon iliac artery 12, occluded segment 14, right common femoral artery18, left common femoral artery 30, renal arteries 20 and right inguinalligament 19. In FIGS. 1 and 2, a blood vessel is shown, generallydesignated by the reference numeral 11, which includes aorta 16, rightcommon iliac artery 12, right common femoral artery 18 and left commonfemoral artery 30. Blood vessel 11, when not occluded, conveys bloodfrom a point C within aorta 16 to a point D within right common femoralartery 18 (see FIGS. 1–2). However, due to the presence of occludedsegment 14, blood is substantially totally precluded from being conveyedfrom point C within aorta 16 to point D within right common femoralartery 18 via the direct route of right common iliac artery 12. Whilethe inventive method will hereinafter be described with regard to asubstantially totally occluded segment of a blood vessel of a patient,it will be understood to one skilled in the art that the inventivemethod is equally effective for bypass of a partially occluded segmentof a blood vessel. In addition, the inventive method is also useful forbypass of an aneurysmal segment of a blood is vessel.

Referring now to FIGS. 3–24, successive steps according to the preferredmethod of the present invention are depicted of the implantation of agraft prosthesis of the present invention to couple aorta 16 to rightcommon femoral artery 18 thereby bypassing occluded segment 14 of bloodvessel 11.

One step of the preferred method of the present invention comprisesisolating a region of the area within the blood vessel 11, located neara site 21 (see FIG. 4) upstream of occluded segment 14, from fluidcommunication with the rest of the area within the blood vessel. Therealso exists a site 31 which is located downstream of occluded segment 14(see FIG. 4). Upstream site 21 is located substantially adjacent theblood vessel 11 and designates a working area where the distal end ofmedical instruments and various medical devices may be positioned duringthe process of securing one end of a graft to the blood vessel.

Upstream site 21 is located near blood vessel 11 so as to allow suchdistal end of medical instruments and medical devices to beappropriately manipulated at upstream site 21 to thereby successfullysecure the one end of the graft to the blood vessel. Downstream site 31is located substantially adjacent the blood vessel 11 and alsodesignates a working area where the distal end of medical instruments,physician's hands and various medical devices may be positioned duringthe process of securing a second end of the graft to the blood vessel.

Downstream site 31 is also located near blood vessel 11 so as to allowsuch distal end of medical instruments, physician's hands and medicaldevices to be appropriately manipulated at downstream site 31 to therebysuccessfully secure the second end of the graft to the blood vessel.Referring now to FIG. 3, a balloon-tip catheter 22 having a balloon 24thereon is percutaneously inserted into blood vessel 11 via the right orleft axillary artery (not shown). This step may be accomplished usingstandard catherization techniques. The distal end of catheter 22 is thenadvanced into aorta 16 until balloon 24 is positioned distal to renalarteries 20 as shown in FIG. 3. Balloon 24 is then inflated to andmaintained at a size such that fluid communication is substantiallyterminated in aorta 16 between the portion of blood vessel 11 proximalto balloon 24 and the portion of blood vessel 11 distal to balloon 24.Since conventional balloon-tip catheters may not have a balloon thereonthat possess the characteristics necessary to terminate fluidcommunication in the aorta as described above, modification may bereadily made to an existing design of a conventional balloon-tipcatheter to achieve the above desired results. One such modificationwould include providing a balloon on the catheter with is inflatable toan outer diameter which is larger than the inner diameter of the aorta.Another such modification would include providing a coarse texturedouter surface to the balloon of the catheter. The above modificationwould provide increased frictional resistance between the inflatedballoon and the sidewall of the blood vessel when force is applied tothe balloon in the axial direction thereof. A balloon-tip catheterhaving a conventional design is available through Medi-tech,Incorporated of Watertown, Mass., as Order No. 17-207 (Description:OBW/40/8/2/100).

Referring now to FIG. 4, a balloon-tip catheter 26 having a balloon 28thereon and an open lumen defined therein is percutaneously insertedinto blood vessel 11 via the left common femoral artery 30. This stepmay be accomplished using standard catherization techniques. The distalend of the catheter 26 is then advanced into aorta 16 until balloon 28is positioned proximal to the aortic bifurcation. Balloon 28 is theninflated to and maintained at a size such that fluid communication issubstantially terminated in aorta 16 between the portion of blood vessel11 proximal to balloon 28 and the portion of blood vessel 11 distal toballoon 28. Since conventional balloon-tip catheters may not have aballoon thereon that possess the characteristics necessary to terminatefluid communication in the aorta as described above, modificationsimilar to that described with respect to catheter 22 may need to bemade to catheter 26. In addition, further modification may need to bemade to catheter 26 since a conventional balloon-tip catheter may nothave an open central lumen defined therein which possesses a diameterlarge enough for the advancement therethrough of a compressed stentmounted on a balloon of another balloon-tip catheter as will be requiredby the preferred method of the present invention (see FIG. 17). Suchfurther modification would be to create an open central lumen incatheter 26 that possesses a diameter larger than the outer diameter ofthe compressed stent which is mounted on the balloon of the balloon-tipcatheter as referred to above. Due to the increased size requirements ofcatheter 26 as alluded to above, a surgical cut-down may need to beperformed in order to expose left common femoral artery 30. Suchexposure would facilitate both placement of catheter 26 into bloodvessel 11 and repair of such blood vessel following subsequent removalof such catheter therefrom.

Temporary occlusion of the blood flow in the inferior mesenteric artery(not shown) by laparoscopic procedures may need to be performed in orderto prevent the flow of blood from the inferior mesenteric artery intoaorta 16 due to placement of inflated balloons 24 and 28 as discussedabove.

The region bound by balloon 24 of catheter 22 and balloon 28 of catheter26 and the sidewall of blood vessel 11 contained therebetween defines aregion 40 of the area within blood vessel 11, located near site 21upstream of occluded segment 14, which is substantially isolated fromfluid communication with the rest of the area within blood vessel 11.

Alternatively, the step of isolating the region of the area within bloodvessel 11, located near upstream site 21, from fluid communication withthe rest of the area within the blood vessel may be accomplished bylaparoscopically placing a first clamp around the blood vessel 11 at thelocation where balloon 24 of the balloon-tip catheter 22 was describedas having been inflated and also laparoscopically placing a second clamparound the blood vessel 11 at the location where balloon 28 of theballoon-Up catheter 26 was described as having been inflated.

Another step according to the method of the present invention comprisesmaking an arteriotomy in the sidewall of blood vessel 11, near upstreamsite 21, to create a communicating aperture between upstream isolatedregion 40 and the outside of blood vessel 11.

Referring now to FIG. 5, right common femoral artery 18 and rightinguinal ligament 19 are exposed via a surgical incision 17. Suchexposure is accomplished using standard surgical techniques.

Insufflation of the peritoneal cavity is then performed using standardtechniques associated with laparoscopy. A laparoscope 37 (see FIG. 6),having an open central lumen (i.e. a working channel) defined therein,is then inserted into human body 10 through the opening between rightcommon femoral artery 18 and right inguinal ligament 19. Laparoscope 37may additionally include a fiber optic illumination device and atelescope for viewing. A tilt table may be used with the patient (i.e.human body 10) positioned thereon in order to maneuver the patient'sabdominal contents away from the laparoscope insertion site and the areanear upstream site 21. Laparoscope 37 is then advanced toward upstreamsite 21 until its distal end is positioned thereat as shown in FIG. 6.One or more additional laparoscopes and associated laparoscopicoperating instruments may be employed using standard laparoscopictechniques to assist in the above positioning via direct visualization,tissue retraction and tissue dissection. One laparoscope which may beused in carrying out the preferred is method of the present invention isavailable through Karl Storz Endoscopy-America, Incorporated of CulverCity, Calif., as Catalog No. 26075A. Modification may be readily made tolaparoscope 37, such as rounding the distal edge thereof, in order toreduce the possibility of tissue trama as a result of advancement oflaparoscope 37 within human body 10. A book which discloses variousstandard laparoscopic techniques and standard associated laparoscopicoperating instruments is entitled “Laparoscopy for Surgeons,” authoredby Barry A. Salky, M. D., published by Igaku-Shoin Medical Publishers,Inc. of New York, N.Y., U.S.A. (1990), and the pertinent part of thedisclosure of which is herein incorporated by reference.

Referring now to FIG. 7, a puncture needle 39 is advanced through theopen central lumen of laparoscope 37 until its distal end exits thelaparoscope. Thereafter, needle 39 is manipulated to penetrate throughthe sidewall of blood vessel 11 to the inside thereof, thus creating apuncture in the blood vessel. Needle 39 is then withdrawn and a scissorsdevice 41 is advanced through the open central lumen of laparoscope 37until its distal end exits the laparoscope (see FIG. 8). The scissorsdevice is then manipulated to enlarge the puncture in the sidewall ofthe blood vessel. Scissors device 41 is then withdrawn from laparoscope37. One puncture needle which may be used in carrying out the preferredmethod of the present invention is available through Karl StorzEndoscopy-America, Incorporated of Culver City, Calif., as Catalog No.26178R. Additionally, one scissors device which may be used in carryingout the method of the present invention is available through Karl StorzEndoscopy-America, Incorporated of Culver City, Calif., as Catalog No.26178PS.

It should be noted that if upstream isolated region 40 was notsubstantially isolated from fluid communication with the rest of thearea within the blood vessel, the act of making an arteriotomy in thesidewall of blood vessel 11 near upstream site 21 would causesignificant blood leakage out of blood vessel 11 and such blood leakagemay be fatal to the patient.

According to another step of the method of the present invention, agraft prosthesis is positioned so that one end of the graft is locatedsubstantially adjacent blood vessel 11 at downstream site 21 and theother end of the graft prosthesis is located substantially adjacentblood vessel 11 at downstream site 31. The above positioning stepincludes the step of advancing the graft prosthesis within the humanbody 10 with a medical instrument.

One type of graft prosthesis which may be used is a graft, generallydesignated by the reference numeral 60 and shown n FIGS. 9A–9E. Graft 60includes a body portion 61 having a length slightly larger than thedistance between upstream site 21 and downstream site 31. Graft 60 hasan outwardly extending flanged end portion 62 as shown in FIGS. 9A, 9C,9D and 9E. End portion 62 is resiliently maintained outwardly extendingby four springs 64A–64D as shown in FIGS. 9B and 9E–9I. In their relaxedstate, springs 64A–64D maintain end portion 62 within a plane P1 asshown in FIG. 9A. It should be noted that a number of springs other thanfour may be used, if desired, to maintain end portion 62 outwardlyextending as previously shown and described. Graft 60 further includes asecond end portion 63 having a design similar to that of a conventionalprosthetic graft as shown in FIG. 9A. Graft 60 is preferably made ofsynthetic fibers. By way of example, graft 60 can be made from thematerial sold under the trademark Dacron by E.I. du Pont de Nemours &Co., Inc. of Wilmington, Del. Body portion 61 and end portion 62 areintegrally formed together with springs 64A–64D maintained integrallywithin the end portion 62 and a portion of the sidewalls of body portion61 as shown in FIGS. 9B and 9E. Graft 60 maintains its shape as shown inFIGS. 9A–9E absent application of external forces thereto and also graft60 will revert back to such shape upon termination of such externalforces thereto.

Graft 60 is positioned within the open central lumen defined inlaparoscope 37. In order to achieve the above, graft 60 is preferablyrolled into a substantially cylindrical shape as shown in FIGS. 10A and10B. End portion 62 of graft 60 is manipulated to lie substantiallyparallel to body portion 61 of graft 60 while graft 60 is in its rolledconfiguration as shown in FIG. 10A. The outer diameter of graft 60, inits rolled configuration, from point W to point Y is larger than theouter diameter of the rolled graft from point Y to point Z as shown inFIG. 10A. The above is due to the angular construction of end portion 62as shown in FIG. 9A. The outer diameter of the rolled graft from point Wto point Y is slightly smaller than the inner diameter of laparoscope37. As a result, in its rolled configuration, graft 60 can be positionedwithin the open central lumen of laparoscope 37. Moreover, graft 60 canbe maintained in its rolled configuration while positioned in thecentral lumen of laparoscope 37 due to the inner diameter thereof. Graft60 is then inserted into the proximal end of the central lumen oflaparoscope 37 and advanced until its full length is entirely therein. Aplunger 82 is insertable into the central lumen of laparoscope 37 asshown in FIGS. 11A and 11B. Plunger 82 has a length sufficient to spanthe length of laparoscope 37. Plunger 82 enables an operator toselectively position graft 60 within body 10. FIGS. 11A and 12 showgraft 60 positioned in the distal portion of the central lumen oflaparoscope 37 after being advanced by plunger 82. Laparoscope 37 withgraft 60 contained therein is then advanced and manipulated such thatthe distal end of the laparoscope is advanced through the communicatingaperture near upstream site 21 and into isolated region 40. While theplunger is held stationary, laparoscope 37 is then withdrawn axiallyover plunger 82 and graft 60 in the direction of arrow 84 assequentially shown in FIGS. 13–15. This allows graft 60 in its rolledconfiguration to be delivered out the distal end of laparoscope 37. FIG.15 shows end portion 62 of graft 60 positioned within upstream isolatedregion 40 and end portion 63 of graft 60 positioned at downstream site31. Since graft 60 is no longer held in its rolled configuration by theinner diameter of the open central lumen of laparoscope 37, graft 60becomes unrolled and reverts to its prerolled configuration as shown inFIG. 16. Injection of a saline solution into graft 60, via end portion63, may be performed to facilitate the reverting of graft 60 to itsprerolled configuration. Alternatively, an additional laparoscope may beused to manipulate graft 60 to its prerolled configuration.Alternatively, a balloon-tip catheter may be advanced into graft 60 viaend portion 63 and the graft converted to its prerolled configuration byinflation and deflation of the balloon along various segments of thegraft.

Also shown in FIG. 16, end portion 62 of graft 60 is positioned withinupstream isolated region 40 near upstream site 21 and end portion 63 ofgraft 60 is positioned at downstream site 31 while body portion 61 ofgraft 60 is positioned outside of blood vessel 11. Note that end portion62 has also reverted back to its prerolled configuration so that suchend portion is outwardly extending relative to body portion 61 of graft60.

Another step according to the preferred method of the present inventionincludes forming an anastomosis between end portion 62 of graft 60 andblood vessel 11 near upstream site 21.

A balloon-tip catheter 86 having a balloon 88 thereon and further havingan expandable stent 90, in its unexpanded configuration, positioned overballoon 88 is advanced through the open central lumen of catheter 26until its distal end is located within upstream isolated region 40 nearupstream site 21 (see FIG. 17). Catheter 86 is further advanced untilballoon 88 is positioned substantially adjacent end portion 62 of graft60 as shown in FIG. 17. Balloon 88 is then inflated to expand stent 90to its expanded configuration such that end portion 62 is securedbetween stent 90 and the sidewall of blood vessel 11 near upstream site21 as shown in FIG. 18. Balloon 88 is then deflated and catheter 86 isthen removed from body 10 via the central lumen of catheter 26. FIG. 19Ashows body 10 after catheter 86 is removed therefrom. Moreover, FIGS.20A–20C show end portion 62 of graft 60 being forced into the sidewallof blood vessel 11 by stent 90 (in its expanded configuration) such thatgraft 60 is secured to blood vessel 11 near upstream site 21 at its endportion 62.

One stent which may be used, with a minor degree of modification, incarrying out the preferred method of the present invention is disclosedin U.S. Pat. No. 4,776,337 issued to Palmaz on Oct. 11, 1988, thepertinent part of the disclosure of which, is herein incorporated byreference. Such modification would be to provide stent 90 with an outerdiameter (in its fully expanded configuration) that is larger than theinner diameter of blood vessel 11 near upstream site 21.

Note that stent 90 includes a plurality of intersecting bars 71 whichspan the orifice of graft 60 near end portion 62 as shown in FIG. 20B.Intersecting bars 71 which span the above orifice do not substantiallyhinder blood flow through the graft orifice as demonstrated by thetechnical article entitled “Intravascular Stents to Prevent Occlusionand Restenosis After Transluminal Angioplasty” which was published inthe Mar. 19, 1987 edition of the periodical “The New England Journal ofMedicine,” the pertinent part of the disclosure of which is hereinincorporated by reference.

Further modification may be readily made to stent 90 whereby stent 90would have an opening defined in its sidewall which is of similardimensions to the orifice of graft 60 near end portion 62. Such openingwould have no intersecting bars traversing thereover. The abovemodification would allow stent 90 to be positioned within blood vessel11 near upstream site 21 wherein the above opening would besubstantially superimposed over the orifice of graft 60 near end portion62. This would allow blood to flow through the connection between bloodvessel 11 and graft 60 near upstream site 21 in an unimpeded manner.

As a possible additional procedure in order to further ensure theintegrity of the anastomosis between end portion 62 of graft 60 andblood vessel 11 near upstream site 21, a number of sutures 100 may betied to the sidewall of blood vessel 11 so as to further secure endportion 62 and stent 90 to the sidewall of blood vessel 11 asschematically shown in FIGS. 19B and 19C. This is accomplished byinserting a laparoscope 102 (which is similar to laparoscope 37) havingan open central lumen into human body 10 until its distal end is nearupstream site 21. Thereafter, a grasper 104 is advanced through thecentral lumen of laparoscope 102. The grasper 104 has in its grasp acurved needle 106 having an end of suture 100 attached thereto as shownin FIG. 19D. By manipulating the distal end of grasper 104, the needle106 and the end of suture 100 are passed through the sidewall of bloodvessel 11 and end portion 62 of graft 60 and into blood vessel 11. Withcontinued manipulation, the needle 106 and the end of suture 100 arethen brought back out of blood vessel 11. The suture 100 is then tied bystandard laparoscopic techniques. One article that refers to standardlaparoscopic techniques for tying sutures is entitled “LaparoscopicCholedocholithotomy”, which was published in Volume 1, Number 2, 1991edition of the “Journal of Laparoendoscopic Surgery” (Mary Ann Liebert,Inc., Publishers), pages 79–82, and another article that refers tostandard laparoscopic techniques for tying sutures is entitled“Improvement in Endoscopic Hemioplasty: Transcutaneous Aquadissection ofthe Musculofascial Defect and Preperitoneal Endoscopic Patch Repair”,which was published in Volume 1, is Number 2, 1991 edition of the“Journal of Laparoendoscopic Surgery” (Mary Ann Liebert, Inc.,Publishers), pages 83–90, the pertinent part of both of the abovearticles of which is herein incorporated by reference. A number of othersutures 100 are then tied to the sidewall of blood vessel 11 and endportion 62 of graft 60 in a manner similar to that hereinbeforedescribed so as to further secure end portion 62 to the sidewall ofblood vessel 11 as schematically shown in FIGS. 19B and 19C. One or moreadditional laparoscopes and associated laparoscopic operatinginstruments may be employed using standard laparoscopic techniques toassist in the above suturing procedure. Of course, sutures 100 may besewn in a conventional running fashion so as to secure end portion 62 tothe sidewall of blood vessel 11. Also, end portion 62 may be sutured tothe sidewall of blood vessel 11 prior to the placement of stent 90within blood vessel 11.

Alternatively, the step of forming an anastomosis between end portion 62of graft 60 and blood vessel 11 near upstream site 21 may beaccomplished by suturing alone (i.e. without the use of stent 90). Inparticular, once end portion 62 of graft 60 is positioned withinupstream isolated region 40 near upstream site 21 as shown in FIG. 16,end portion 62 is sutured to the sidewall of blood vessel 11 asschematically shown in FIGS. 19E and 19F. Note that in this alternativestep, end portion 62 is sutured to an interior portion of blood vessel11 as schematically shown in FIGS. 19E and 19F. Also note that endportion 62 is sutured to the sidewall of blood vessel 11 so as to bepositioned substantially adjacent a portion of the sidewall of bloodvessel 11 which substantially surrounds the arteriotomy. This isaccomplished by tying a number of sutures 110 to the sidewall of bloodvessel 11 and end portion 62 of graft 60 so as to secure end portion 62to the sidewall of blood vessel 11 as schematically shown in FIGS. 19Eand 19F. The sutures 110 shown in FIGS. 19E and 19F are is applied inthe same manner as the sutures 100 shown in FIGS. 19B, 19C and 19D wereapplied as described above. Of course, sutures 110 may be sewn in aconventional running fashion so as to secure end portion 62 to thesidewall of blood vessel 11.

As a further alternative, the end portion 62 of graft 60 need not bepositioned in upstream isolated region 40 but rather end portion 62 maybe positioned adjacent the sidewall of blood vessel 11 so that thecommunicating aperture (i.e. the arteriotomy) in the sidewall of bloodvessel 11 near upstream site 21 is aligned with the central passage ofgraft 60. At this position, end portion 62 is sutured to the sidewall ofblood vessel as schematically shown in FIGS. 19G and 19H. Note that inthis further alternative step, end portion 62 is sutured to an exteriorportion of blood vessel 11 as schematically shown in FIGS. 19G and 19H.Also note that end portion 62 is sutured to the sidewall of blood vessel11 so as to be positioned substantially adjacent a portion of thesidewall of blood vessel 11 which substantially surrounds thearteriotomy. This is accomplished by tying a number of sutures 120 tothe sidewall of blood vessel 11 and end portion 62 of graft 60 so as tosecure end portion 62 to the sidewall of blood vessel 11 asschematically shown in FIGS. 19G and 19H. The sutures 120 shown in FIGS.19G and 19H are applied in the same manner as the sutures 100 shown inFIGS. 19B, 19C and 19D were applied as described above. Of course,sutures 120 may be sewn in a conventional running fashion so as tosecure end portion 62 to the sidewall of blood vessel 11.

The remainder of the preferred method of the present invention isperformed using standard surgical techniques. A book which disclosesvarious standard surgical techniques is entitled “Color Atlas ofVascular Surgery,” authored by John S. P. Lumley, published by WolfeMedical Publications Ltd. of Baltimore, Md. (1986), printed by W. S.Cowell, Ltd. of Ipswich, United Kingdom, and the pertinent part of thedisclosure of which is herein incorporated by reference. Morespecifically, another step according to the preferred method of thepresent invention comprises isolating a region 50 of the area withinblood vessel 11, located near site 31 downstream of occluded segment 14,from fluid communication with the rest of the area within the bloodvessel. Referring now to FIG. 21, a pair of surgical clamps 53 and 55are positioned on blood vessel 11, one being placed upstream of isolatedregion 50 and the other being placed downstream of isolated region 50.

Another step according to the method of the present invention comprisesmaking an arteriotomy in the sidewall of blood vessel 11, neardownstream site 31, to create a communicating aperture betweendownstream isolated region 50 and the outside of the blood vessel 11.End portion 63 of graft 60 is retracted by surgical forceps (not shown)to expose blood vessel 11 near downstream site 31 (see FIG. 22). Ascalpel puncture is then made in blood vessel 11 near downstream site 31and thereafter the puncture is extended to the appropriate length with apair of surgical scissors. FIG. 22 shows the communicating aperturedefined in the sidewall of blood vessel 11, near downstream site 31.

Another step according to the preferred method of the present inventioncomprises forming an anastomosis between end portion 63 of graft 60 andblood vessel 11 near downstream site 31. Graft 60 is then cut to anappropriate length and thereafter end portion 63 is cut an appropriateshape for attachment to blood vessel 11. End portion 63 of graft 60 isthen surgically stitched with suture 65 to blood vessel 11 neardownstream site 31 as shown in FIG. 23.

Clamps 53 and 55 are then removed from blood vessel 11, and moreover,balloons 24 and 28 are then deflated and thereafter catheters 22 and 26are removed from body 10 as shown in FIG. 24. This allows blood to flowto former upstream isolated region 40. Once blood flow reaches formerupstream isolated region 40, a flow of blood will enter graft 60 andflow therethrough to former downstream isolated region 50 therebybypassing occluded segment 14. Consequently, proper blood flow will nowexist in body 10 from point C within aorta 16 to point D within rightcommon femoral artery 18 as a result of performing the above describedmethod of bypass of occluded segment 14.

While the invention has been described in detail in the drawings andforegoing description, the same is to be considered as illustrative andnot restrictive in character, it being understood that only thepreferred embodiments and methods have been shown and described and thatall changes and modifications that come within the spirit of theinvention are desired to be protected.

For instance, it is possible that left common femoral artery 30 and leftinguinal ligament 29 could be exposed via a surgical incision similar tothat of incision 17 as hereinbefore described. Thereafter, a Y-shapedgraft could be utilized instead of graft 60 as hereinbefore disclosed.The Y-shaped graft could be advanced in a rolled configuration throughlaparoscope 37 and delivered to a position substantially adjacent bloodvessel 11 similar in manner to that hereinbefore described. Anadditional laparoscope could be inserted into human body 10 through theopening defined between left common femoral artery 30 and left inguinalligament 29 in a manner substantially similar to that hereinbeforedescribed with respect to the insertion of laparoscope 37 into humanbody 10. The additional laparoscope could be advanced toward the leftlimb of the Y-shaped graft and thereafter used to grasp such limb andpull it toward left common femoral artery 30 and subsequently out of thesurgical incision near the left common femoral artery. The end portionof the left limb of the Y-shaped graft could be cut to an appropriatelength and shape, and thereafter, an anastomosis could be made betweensuch end portion and left common femoral artery 30 similar in manner tothat hereinbefore described with regard to right common femoral artery18 and end portion 63 of graft 60.

Moreover, for example, it is possible that a graft may be utilized whichwould be similar to graft 60 hereinbefore described, however, both endportions of such graft could be similar in structure to end portion 62of graft 60. In other words, each graft end could posses an end portionthat is resiliently maintained outwardly extending relative to the bodyportion of the graft. A catheter could be placed into blood vessel 11 atright femoral artery 18 and advanced toward occluded segment 14. Priorto arriving at occluded segment 14, the distal end of the catheter couldbe manipulated and guided but of blood vessel 11 through a puncture sitelaparoscopically created in the blood vessel in a manner similar to thathereinbefore described. The catheter could then be advancedsubstantially adjacent blood vessel 11 over and past occluded segment14. One or more additional laparoscopes could assist in the aboveadvancement. The distal end of the catheter could then be manipulatedand guided to reenter blood vessel 11 at a site upstream of occludedsegment 14 through a puncture site laparoscopically created in bloodvessel 11 in a manner similar to that hereinbefore described. The grafthaving a resiliently outwardly extending end portion at each end thereofcould then be advanced in rolled configuration through the catheter anddelivered to a position substantially adjacent blood vessel 11 similarin manner to that hereinbefore described with respect to graft 60 andlaparoscope 37. The graft could have a predetermined length equal to alength slightly larger than the distance between the puncture sitelocated upstream of occluded segment 14 and the puncture site locateddownstream of occluded segment 14. As a result, the distal end portionof the graft could be positioned within blood vessel 11 at a locationupstream of occluded segment 14 and the proximal end portion of thegraft could be positioned within blood vessel 11 at a locationdownstream of occluded segment 14 while the body portion of the graftcould be positioned substantially adjacent and outside of blood vessel11. Of course, an area within the blood vessel near each end portion ofthe graft could be isolated from fluid communication with the rest ofthe area within the blood vessel in a manner substantially similar tothat hereinbefore described with respect to upstream isolated region 40.After being advanced out the distal end of the catheter, the graft(including each outwardly extending end portion) could revert back toits prerolled configuration as hereinbefore described with respect tograft 60. Thereafter, a stent could be placed, in an expandedconfiguration, adjacent each of the end portions of the graft withinblood vessel 11 in order to secure such end portions of the graft toblood vessel 11 as hereinbefore described with respect to stent 90 andend portion 62 of graft 60.

1. A method for connecting a graft conduit to the aorta in a patient'sbody, the method comprising: forming an incision in the body of thepatient to expose a femoral artery; extending upwardly through theincision toward the aorta an elongated surgical instrument including alumen therein between distal and proximal ends thereof; performing anaortotomy at a site along the aorta through the lumen of the surgicalinstrument; positioning one end of the graft conduit at the site throughthe lumen of the surgical instrument; forming an anastomosis of the oneend of the graft conduit with the aorta at the site of the aortotomy;and attaching another end of the graft conduit to a blood vessel in thebody of the patient.
 2. A method for connecting to the aorta in apatient's body a graft conduit including a body portion and an endportion, the method comprising: forming an incision in the body of thepatient to expose a femoral artery; extending through the incisiontoward the aorta an elongated surgical instrument including a lumentherein between distal and proximal ends thereof; performing anaortotomy at a site along the aorta through the lumen of the surgicalinstrument; collapsing the graft conduit to dimension smaller than thecross-sectional dimension of the lumen of the surgical instrument;positioning one end of the graft conduit at the site through the lumenof the surgical instrument; expanding the end portion of the graftconduit into contact with the walls of the aorta to secure the bodyportion of the graft conduit in position through the aortotomy; formingan anastomosis of the one end of the graft conduit with the aorta at thesite of the aortotomy with the end portion positioned along the aortaand with the body portion protruding through the aortotomy; attachingthe end portion of the graft conduit to the aorta with the body portionprotruding outside the aorta; and attaching another end of the graftconduit to a blood vessel in the body of the patient.
 3. The methodaccording to claim 2 in which positioning the end portion of the graftconduit also includes inserting the collapsed graft conduitintralumenally within the aorta from a location downstream of the site.4. A method for connecting a graft conduit to the aorta in a patient'sbody, the method comprising: forming an incision in the body of thepatient to expose a femoral artery; extending through the incisiontoward the aorta an elongated surgical instrument including a lumentherein between distal and proximal ends thereof; performing anaortotomy at a site along the aorta through the lumen of the surgicalinstrument; positioning one end of the graft conduit at the site throughthe lumen of the surgical instrument; expanding a balloon within theaorta to urge the one end of the graft conduit into contact with thewalls of the aorta in response to fluid under pressure supplied to theballoon; forming an anastomosis of the one end of the graft conduit withthe aorta at the site of the aortotomy; and attaching another end of thegraft conduit to a blood vessel in the body of the patient.
 5. Themethod according to claim 4 further including installing a fluid conduitalong a portion of the aorta downstream of the aortotomy for supplyingfluid under pressure to inflate the balloon.
 6. The method according toclaim 5 in which the fluid conduit is disposed intralumenally along thedownstream portion of the aorta between the site and a location along afemoral artery.